Extension Study to Evaluate the Safety of Long-Term Use of Relacorilant in Patients With Cushing Syndrome

Last updated: May 1, 2025
Sponsor: Corcept Therapeutics
Overall Status: Active - Not Recruiting

Phase

2

Condition

Female Hormonal Deficiencies/abnormalities

Cushing's Disease

Treatment

relacorilant

Clinical Study ID

NCT03604198
CORT125134-452
  • All Genders

Study Summary

This is an open-label extension study to evaluate the long-term safety of relacorilant in patients with endogenous Cushing syndrome who successfully completed participation in a Corcept-sponsored study of relacorilant and may benefit from continuing treatment.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Major Inclusion Criteria:

  • Have completed a Corcept-sponsored study of relacorilant in endogenous Cushingsyndrome with at least 80% compliance with the dosing schedule.

  • According to the Investigator's opinion will benefit from continuing treatmentwith relacorilant

Exclusion

Exclusion Criteria:

  • Major Exclusion Criteria:

  • Premature discontinuation from a relacorilant parent study.

  • Has uncontrolled, clinically significant hypothyroidism or hyperthyroidism

  • Has poorly controlled hypertension

  • Has Stage ≥ 4 renal failure

Study Design

Total Participants: 125
Treatment Group(s): 1
Primary Treatment: relacorilant
Phase: 2
Study Start date:
May 07, 2018
Estimated Completion Date:
December 31, 2025

Study Description

This study is designed to allow continued therapy with relacorilant, a potent, selective glucocorticoid receptor (GR) antagonist in patients who have successfully completed participation of a Corcept-sponsored study of relacorilant (referred to as the "parent" study). Patients may qualify to enter this extension study if they complete their last treatment visit in their parent study and in the Investigator's opinion will benefit from continued treatment.

Once-daily dosing with relacorilant may continue for patients who receive clinical benefits (as judged by the Investigator) until relacorilant is commercially or otherwise available or the study is stopped by the Sponsor. A patient's dose may be maintained, reduced, or increased based on individual response and tolerability.

Connect with a study center

  • Site 14

    Wien, 1090
    Austria

    Site Not Available

  • Site 15

    Sofia, 1431
    Bulgaria

    Site Not Available

  • Site 51

    Nova Scotia,
    Canada

    Site Not Available

  • Site 16

    Munich,
    Germany

    Site Not Available

  • Site 42

    Wuerzburg, 97080
    Germany

    Site Not Available

  • Site 20

    Ramat Gan, 5265601
    Israel

    Site Not Available

  • Site 29

    Tel Aviv, 64239
    Israel

    Site Not Available

  • Site 40

    Ancona, 60126
    Italy

    Site Not Available

  • Site 44

    Messina, 98125
    Italy

    Site Not Available

  • Site 25

    Milano, 20145
    Italy

    Site Not Available

  • Site 21

    Napoli, 80131
    Italy

    Site Not Available

  • Site 48

    Padova, 35128
    Italy

    Site Not Available

  • Site 22

    Roma, 00189
    Italy

    Site Not Available

  • Site 23

    Roma, 00161
    Italy

    Site Not Available

  • Site 52

    Torino,
    Italy

    Site Not Available

  • Site 33

    Rotterdam, 3015 GD
    Netherlands

    Site Not Available

  • Site 47

    Kraków, 30-688
    Poland

    Site Not Available

  • Site 45

    Lublin, 20412
    Poland

    Site Not Available

  • Site 28

    Bucharest, 11863
    Romania

    Site Not Available

  • Site 31

    Bucuresti, 10825
    Romania

    Site Not Available

  • Site 37

    Bucuresti, 050474
    Romania

    Site Not Available

  • Site 53

    Alicante,
    Spain

    Site Not Available

  • Site 18

    Girona,
    Spain

    Site Not Available

  • Site 17

    Madrid, 28007
    Spain

    Site Not Available

  • Site 38

    Málaga, 29006
    Spain

    Site Not Available

  • Site 19

    Sevilla,
    Spain

    Site Not Available

  • Site 49

    Phoenix, Arizona 85013
    United States

    Site Not Available

  • Site 35

    Stanford, California 94305
    United States

    Site Not Available

  • Site 39

    Torrance, California 90502
    United States

    Site Not Available

  • Not Provided

    Fort Lauderdale, Florida 33312
    United States

    Site Not Available

  • Site 50

    Miami, Florida 33136
    United States

    Site Not Available

  • Site 10

    Atlanta, Georgia 30318
    United States

    Site Not Available

  • Site 9

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Site 1

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Site 5

    Metairie, Louisiana 70006
    United States

    Site Not Available

  • Site 27

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Site 13

    Fall River, Massachusetts 02721
    United States

    Site Not Available

  • Site 8

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Site 36

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Site 34

    Jackson, Mississippi 39202
    United States

    Site Not Available

  • Site 3

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Site 55

    Reno, Nevada 89511
    United States

    Site Not Available

  • Site 6

    Albany, New York 12206
    United States

    Site Not Available

  • Site 24

    New York, New York 10021
    United States

    Site Not Available

  • Site 4

    Wilmington, North Carolina 28401
    United States

    Site Not Available

  • Site 43

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Site 41

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Site 30

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Site 2

    Pittsburgh, Pennsylvania 15212
    United States

    Site Not Available

  • Site 46

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Site 11

    Dallas, Texas 75390
    United States

    Site Not Available

  • Site 7

    El Paso, Texas 79935
    United States

    Site Not Available

  • Site 32

    Fort Worth, Texas 76132
    United States

    Site Not Available

  • Site 12

    Houston, Texas 77079
    United States

    Site Not Available

  • Site 26

    Spokane, Washington 99202
    United States

    Site Not Available

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